General Information

Location: Remote

Organization: Avoca

Job Type: Full Time - Regular

Description and Requirements

JOB SUMMARY: The Clinical Development SME is responsible for leading the delivery of WCG Avoca’s Consulting solutions and ensuring that services successfully meet the needs and expectations of clients. The SME is an experienced industry professional who is able to perform gap analyses for clients and design and implement solutions in a fit-for-purpose way. The SME must have a deep understanding of GCP and substantial knowledge of clinical research, with expertise in relevant specialty areas such as quality systems, risk management, outsourcing models, effective oversight, clinical operations, and change management. This role works on the Client Delivery team and collaborates closely with senior consultants, project managers, and internal staff while managing client relationships at complex clinical development organizations.

VACCINATION REQUIREMENT:

To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.

EDUCATION REQUIREMENTS:

·       Bachelor’s degree required.

QUALIFICATIONS/EXPERIENCE:

  • Substantial knowledge of clinical research, with a deep understanding of Quality Management Systems, Risk Management, Vendor Oversight, Inspection Readiness, Quality by Design (QbD) Principles, Clinical Trial Technologies, Quality Metrics, and SOP Development.
  • Experience working in a senior role in CRO/Pharmaceutical industry or as a consultant in the industry
  • Strong working knowledge of ICH E6 (R3) and regulatory requirements for proactive risk and quality management, including sponsor obligations for oversight of service providersA proven track record of successfully adding value to client teams and demonstrating excellent decision making/problem solving skills
  • Outstanding written and oral communication skills, including presentation and reporting skills via MS PowerPoint

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.

  • Lead client consulting projects, managing internal and external resources and leveraging deep industry expertise to design and implement fit-for-purpose solutions
  • time deliverables and high-quality service for our clients
  • Draft, review and edit leading practices, SOPs and supporting process documents to match ICH E6 (R3) and other regulatory requirements
  • Partner with Avoca business development colleagues to meet with prospective clients and demonstrate Avoca’s ability to offer solutions to clients’ specific needs
  • Review and help scope out project proposals to creatively propose solutions to address client needs
  • Nurture relationships with clients and proactively seek to understand client needs in order to provide an optimal mix of services
  • Manage client expectations and look at issues through a business development/relationship management lens.
  • Ability to multitask effectively to meet the needs of diverse stakeholders and projects.
  • paced, entrepreneurial environment.
  • Self-driven with a sense of urgency and the ability to work effectively and independently in a virtual company environment.
  • Bring solutions to the industry and have a desire to make a tangible difference for our clients.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
  • Consistent and predictable attendance and punctuality are essential functions of the position.

SUPERVISORY RESPONSIBILITIES: None.

TRAVEL REQUIREMENTS: 5-10%